Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion

Arrhythmias, Cardiac Clinical Trial

Official title:

Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01088308
• Other study ID #: TPS1010
• Status: Terminated
• Phase: N/A
• First received: March 11, 2010
• Last updated: July 8, 2016
• Start date: March 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2016
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

This research study is a prospective, single-center, feasibility study designed to assess the possibility to detect hemodynamic changes during tachycardia episodes using tissue perfusion.

Description:

This study is being conducted to evaluate the feasibility to detect hemodynamic changes induced by supra-ventricular or ventricular tachycardia (SVT or VT) using tissue perfusion. Patients with a standard indication for either an electrophysiological study or an implantable cardioverter defibrillators(ICD) implant can be included into this study. Tissue perfusion and arterial blood pressure will be monitored and recorded throughout the electrophysiological procedure or ICD implant testing.

The study will be conducted in two consecutive phases. After completion of study phase I the study phase II will commence. Study phase I will be an acute non-invasive study in patients with an indication for an electrophysiological study, in whom tissue perfusion will be measured non-invasively with an epi-cutaneous tissue perfusion sensor. Phase II will be an acute invasive study in patients with an indication for the implantation of an ICD, in whom the tissue perfusion sensor will be placed in the surgically prepared device pocket on the muscular pectoralis or between the muscular pectoralis major and muscular pectoralis minor.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for: an electrophysiological study with ventricular stimulation OR the implantation of an implantable cardioverter defibrillator (ICD)

• Patient is at least 18 years old.

• Patient is able and willing to give informed consent.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Tachycardia

Intervention

Procedure:
• High rate atrial and vetricular stimulation
The right atria and ventricle of the subject will be electrically stimulated at high rate mimicking tachycardia episodes using electrodes placed in the right atria and ventricle.
• Ventricular Tachycardia induction
A programmed electrical stimulation protocol will be performed using an electrode placed in the right ventricle.

Locations

Country	Name	City	State
Germany	Universitätsklinikum	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemodynamic state during all tachycardia	The primary objective is to demonstrate for all tachycardia (supra-ventricular and ventricular tachycardia) a 90 % [two sided confidence interval of 75-100 %] agreement between the true hemodynamic state (stable or unstable) derived from arterial blood pressure measurement and the hemodynamic state determined by tissue perfusion	<3 hours	No
Secondary	Change in hemodynamic state during SVT	The secondary objective is to demonstrate for supra-ventricular tachycardia a 90 % [two sided confidence interval of 75-100 %] agreement between the true hemodynamic state (stable or unstable) derived from arterial blood pressure measurement and the hemodynamic state determined by tissue perfusion.	<3 hours	No